Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety

The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. The investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from PCICU to the ward.

Study Overview

• Status: Completed
• Conditions: Parental Anxiety; Children's Safety
• Intervention / Treatment: Other: Parental Presence at Handover Rounds

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Pediatric Cardiac ICU, Stollery Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents of cardiac children aged 1 day to 17 years admitted to PCICU
• Written informed consent and assent when appropriate
• Planned discharge from the PCICU to the ward.

Exclusion Criteria:

• Parents with less than grade 6 reading skills as they will not be able to independently take the Spielberger's State -Trait Anxiety Inventory (STAI).
• Parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds.
• Neonates being discharged from PCICU to NICU or neonates being discharged from NICU to wards.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Parental Presence at Handover Rounds; Subjects will receive an educational document prior to transfer rounds introducing the concept of Patient and Family Centered Care and the role of a parent in transfer rounds. These parents will have the option of meeting with a parental peer support person for a "coaching" or training session prior to their participation in transfer rounds. During the transfer rounds parents will be actively included in discussion of their child's medical management plan upon discharge to the wards.

Other: Parental Presence at Handover Rounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in parental STAI score	Speilberger State-Trait Anxiety Inventory will be administered to participating parents both prior to and post transfer of their child out of the pediatric cardiac ICU.	2 to 4 hours post transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of unplanned changes in medication and nutrition management	Medication and nutritional order reconciliation will occur 48 hours after transfer from the PCICU. The pharmacist, dietician and physician who review the patient charts and order sheets will be blinded to the randomization. Differences between pre and post transfer orders will be discussed to detect omissions and/or deviation from standard of care.	48 hours post transfer

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Medical Protective Association
• Investigators: Principal Investigator: Ian Adatia, MBChB, MRCP, FRCP(C), Stollery Children's Hospital, University of Alberta

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Parental anxiety; Children's safety; Family Centered Care; Bedside Transfer Rounds; Pediatric Cardiac Intensive Care
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Pro 00037475

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No